MHRA paediatric investigation plan
Vimizim 1mg/ml concentrate for solution for infusion (elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase))
MHRA paediatric investigation plan MHRA-101149-PIP01-23-M01 (update) · Modification
Key facts
| PIP number | MHRA-101149-PIP01-23-M01 (update) |
|---|---|
| Product names | Vimizim 1mg/ml concentrate for solution for infusion |
| Active substances | elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase) |
| Therapeutic areas | Endocrinology-Gynaecology-Fertility-metabolism |
| Conditions | Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome) |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Full |
| Published | Dec 19, 2023 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: